There are many patients affected with disease or other physiological conditions that result in the inability to receive nutrition normally through the mouth which is then swallowed and broken down and absorbed by the digestive system. People suffering from stroke, Alzheimer's disease, cancer, inflammation or other infirmities, often cannot properly chew or swallow their food or medication which must then be delivered to the patient in another fashion if starvation and malnutrition are to be avoided.
Gastroenterologic feeding tubes have been known for years and are inserted into the stomach by any one of a number of different methods. Generally, a catheter is placed in the body by way of the mouth and is either pulled or pushed downward into the stomach and either left there or is pushed further down into the jejunum of the small intestine. The feeding tubes may also enter the body either by way of the nasal passageway or by means of a gastrostomy in which they are surgically implanted through the abdomen.
The present invention relates to the enteral feeding of patients by these tubes and more particularly to a gastrostomy or jejunal feeding tube which is receivable through the wall of the stomach for feeding and medicating a patient and/or for draining fluids from the patient's stomach. The present invention also relates a jejunostomy tube which similarly is receivable into the small intestine from outside the patient's abdomen.
The use of feeding tubes which extend directly into the stomachs of patients is often required when patients cannot swallow or when they have structures in their esophagi which prevent food from entering their stomachs. In a situation of this type, it is common to perform a gastrostomy on a patient wherein an opening is formed in the skin, facia and stomach wall and wherein a gastrostomy tube is installed in the opening to allow food and/or medication to be passed directly into the stomach and also to allow fluid to be drained therefrom.
Enteral feeding tubes that enter the stomach through a surgically incised opening through the skin, facia and peritoneum must be secured in some manner so that the tube does not move about within the patient or fall out altogether if pulled. Generally, enteral or gastrostomy feeding tubes are either surgically inserted through the skin of the abdomen or fed down to the stomach by way of the mouth and pharynx.
Various types of gastrostomy devices have been installed in patients by means of a percutaneous insertion, a surgical placement, a radiological placement or others. The procedures employed generally follow those known as the Sachs-Vine procedure, the Gauderer and Ponsky procedure, and others. Typical patents describing these procedures and publications of the technique are set forth in U.S. Pat. Nos. 4,861,334 to Nawaz 4,900,306 to Quinn et al. and 5,080,650 to Hirsch et al. which are hereby incorporated by reference.
Once installed, these devices are retained in place by an internal retention member. Various types of these internal retention members currently exist, one type being a molded or permanently attached flange element, and another type being a bumper collar and a third type being a balloon.
Removal of gastrostomy devices is needed upon conclusion of enteral nutrition of a patient, or if the device is to be replaced with another enteral feeding device (e.g., an inflatable, replaceable gastrostomy tube), and various techniques are currently used for this removal procedure. These techniques include (1) cutting the gastrostomy tube at skin level and retrieving the bumper endoscopically; (2) cutting the gastrostomy tube past skin level and allowing the flange or collar to pass through the gastrointestinal tract for expulsion by excretion; or (3) physically pulling the internal retention device through the patient's stoma.
Problems exist with the methods known in the prior art particularly with respect to the removal of the retention means through the surgical incision when enteral feeding or medication is concluded. Since the retention means must generally possess an extended surface area or circumference that is greater than the tube itself, movement of this portion of the device can result in tissue damage and/or irritation as the enteral feeding tube is pulled through the esophagus, stomach, intestines and/or the surgical incision. This can result in considerable trauma and/or bleeding within the patient.
There have been a number of attempts in the prior art which have addressed, but not necessarily solved this problem. U.S. Pat. No. 5,336,391 to Stewart discloses a gastrostomy feeding tube with a flexible retainer that consists essentially of a dome or cup-shaped flange is allegedly designed to collapse significantly in diameter when a force is applied longitudinally along the central axis of the enteral feeding tube. The collapsing function of this placement dome is asserted to allow for the easier passage of the retention means during either placement or removal of the gastrostomy feeding tube.
U.S. Pat. No. 5,112,310 to Grobe discloses a percutaneous gastrostomy feeding tube in which the retention means consists of a collapsible basket-shaped device including a plurality of elongated flexible or deformable, but relatively stiff ribs circumferentially spaced one from the other. The ribs are secured at one end to a collar that is fixed to the feeding tube and at the opposite end the ribs are attached to a collar that is slidably attached to the tube. Movement of the slidable collar when force is applied to the basket from the opposite side ostensibly deforms or collapses the basket thereby narrowing its diameter so that the tube may be moved within or withdrawn from the patient's body.
U.S. Pat. No. 5,098,378 to Piontek et al. discloses and claims a replacement gastrostomy tube for jejunal feeding in which an expandable component of the tube is located at the distal end thereof. Fluid is passed through a fluid flow channel which enters the expandable component and inflates it like a balloon. In this fashion, the balloon and an adjacent retention device are pressed against the wall of the stomach, securing the feeding tube in the stoma. Draining the fluid from the balloon deflates it for easier removal.
U.S. Pat. No. 4,668,225 to Russo et al. discloses and claims an enteral gastrostomy feeding tube comprising a retainer element consisting of a plurality of circumferentially spaced resilient leaves or flanges with a rounded configuration that extend outwardly from the feeding tube. The retention means also consists of three hub portions which extend outwardly to a lesser extent between the leaves. The "petals" or "leaves" of the retainer element engage the inner surface of the stomach wall with the feeding tube passing centrally therethrough. These would appear to cause considerable abrasion upon removal however.
None of these prior art feeding tubes and their associated retention means provide a superior means for securing the feeding tube to the interior wall of the stomach with a rigid mounting while at the same time being flexible enough to collapse upon applying a lateral force thereto so as to readily and easily pass through a surgical ostomy or other internal cavity without damaging the surrounding tissue.